Provider Perceptions of Neuromuscular Blockade in ARDS

Acute Respiratory Distress Syndrome Clinical Trial

Official title:

Provider Perceptions of Neuromuscular Blockade in ARDS

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03179709
• Other study ID #: 170115
• Secondary ID: U01HL123020
• Status: Completed
• Start date: July 1, 2017
• Est. completion date: March 18, 2018

Study information

• Verified date: January 2020
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The proposed study will use qualitative methodology to understand health care provider perceptions of neuromuscular blockade (NMB) in patients with Acute Respiratory Distress Syndrome (ARDS). To achieve this goal the investigators will conduct a prospective ancillary study at four clinical centers participating in the NHLBI PETAL network as part of the ROSE (Reevaluation of Systemic Early Neuromuscular Blockade) clinical trial (NCT02509078). Using thematic content analysis of semistructured interviews with health care providers caring for patients enrolled in the ROSE trial the investigators will determine the barriers to NMB use and develop a framework for future NMB adoption in ARDS.

Description:

Efficient translation of clinical trial results into practice is an enduring challenge in critical care, with many critically ill patients not receiving evidence-based therapies proven to save lives. One approach to speed the translation of clinical trial evidence into practice is through qualitative research to better understand the barriers to evidence-based care and help design innovative interventions to overcome those barriers.. This work need not wait until the clinical trial is complete—an emerging literature highlights the value of qualitative research concurrent with the conduct of a clinical trial. Such research has several potential benefits, including facilitating implementation of the intervention in the real world, identifying the potential mechanism of action, and identifying contextual factors necessary for the treatments effectiveness.

The Reevaluation Of Systemic Early Neuromuscular Blockade (ROSE) study, conducted by the NHLBI PETAL Clinical Trials Network, is an ideal trial for which to perform a concurrent qualitative implementation study (NCT02509078). NMB has the potential to substantially reduce mortality in ARDS. Yet NMB remains incompletely adopted for reasons that are poorly understood but likely relate to clinical equipoise, historical concerns about safety, and the inherent difficulties in providing complex practices in the intensive care unit (ICU). A better understanding of provider views regarding NMB will provide essential data to aid interpretation of study results and design an implementation study should ROSE demonstrate a survival benefit with NMB.

To examine this issue the investigators will perform a prospective qualitative study using semi-structured interviews health care professionals providing direct care for patients enrolled in ROSE. A trained research coordinator will perform semi-structured interviews with consenting participants. Interviews will be transcribed and uploaded into commercially available qualitative data software. Trained qualitative researchers will read and code each interview based on Consolidated Framework for Implementation Research, a widely accepted conceptual theory of evidence-uptake.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: March 18, 2018
• Est. primary completion date: March 18, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• physician, nurse, respiratory therapist or clinical pharmacist providing direct care for patients enrolled in the ROSE study; or physician who refused entry of their patient into the ROSE study

Exclusion Criteria:

• none

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Respiratory Distress Syndrome
• Neuromuscular Blockade
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn

Intervention

Behavioral:
• Interview
The investigators will perform and analyze semi-structured interviews with enrolled participants.

Locations

Country	Name	City	State
United States	University of Pittburgh Medical Center	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Barriers to adoption of NMB	As a qualitative study, this study has no quantitative outcome measures. Provider perceptions of the knowledge, attitude, and behavioral barriers to adoption of early NMB in ARDS will be assessed using a semi-structured interview guide.	1 month post enrollment
Primary	Contextual factors that influence the effectiveness of NMB	As a qualitative study, this study has no quantitative outcome measures. Provider perceptions of the clinical and organizational factors that influence the impact of NMB on patient centered outcomes will be assessed using a semi-structured interview guide.	1 month post enrollment